Revised ERP Proposal SPSFAM Food Allergens

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Stakeholder Panel on Strategic Food Analytical Methods Expert Review Panels for ‐SPSFAM Select Food Allergen Methods‐

EXPERT REVIEW PANEL CANDIDATES FOR OFFICIAL METHODS BOARD APPROVAL

Expected to Convene: September 19, 2016 SHERATON DALLAS HOTEL Dallas, Texas, USA

Expert Review Panel for SPSFAM Food Allergens

TABLE OF CONTENTS

I. LIST OF METHODS ............................................................................................................................. 3 II. LIST OF ALL APPLICANTS ............................................................................................................... 4 III. PROPOSED EXPERT REVIEW PANELISTS ............................................................................................ 5 IV. PERSPECTIVES OF APPLICANTS AND RECOMMENDED PANELISTS................................................... 6 V. SUMMARIES OF EXPERTISE .............................................................................................................. 8 VI. CVs OF RECOMMENDED PANELISTS ............................................................................................. 13

AOAC INTERNATIONAL: Expert Review Panel for SPSFAM Food Allergen Methods:

APPLICABLE SMPR(s):

 AOAC SMPR 2016.002, Standard Method Performance Requirements (SMPRs®) for Detection and Quantitation of Selected Food Allergens

LIST OF METHODS SUBMITTED IN RESPONSE TO CALL FOR METHOS:

 ALL‐01: Detection and Quantitation of Selected Food Allergens using LC‐MS/MS o Author(s): Lee Sun New, Hua‐Fen Liu, Andre Schreiber, Vincent Paez o Submitted by: Andre Schreiber, SCIEX  ALL‐02: Multiplexed LC‐MS Method for the Detection and Quantitation of Selected Food Allergens (milk, hazelnut, peanut and whole egg) o Author(s): Jennifer Sealey Voyksner, Jerry Zweigenbaum and Robert Voyksner o Submitted by: Jennifer Sealey Voyksner, ImmunogenX

LIST OF ALL APPLICANTS

Name

Affiliation

Country

1. 2. 3. 4. 5. 6. 7. 8. 9.

Almy, David

Neogen Corporation Mérieux NutriSciences

USA USA USA India

Bhandari, Sneh

Blagoyevich, Philip Chatterjee, Jyotismita

Blagoyevich Consulting Services

Dietitian

Hamta, Purnomo Hassanin, Ashraf

Islamic University of Sultan Syarif Kasim Riau Central Lab. Of Residue Analysis of Pesticides

Indonesia

Egypt

Hilda, Adhe

Fisheries Processing

Indonesia

Ibrahima, Sanou Ismail, Kareem

National Laboratory for Public Health

Burkina Faso

Holding Company for Water and Wastewater; Reference Lab for Drinking Water

Egypt

10. Kareem, Shakir 11. Kausar, Rabia 12. Lawry, John 13. Monaci, Linda 14. Nguyen, Minh Hai 15. Paucar Oré, Fiorela 16. Siebeneicher, Susanne 17. Tuzimski, Tomasz 19. Cho, France 20. Davenport, Ken 21. Downs, Melanie 22. Ehling, Stefan 23. Farrow, Michael 24. Nishiyama, Yasutaka 18. Boudichon, Francois

Ministry of Marine Resources

Cook Islands

Dalda Foods Pvt. Ltd. Lahore Pakistan

Pakistan

Covance

USA Italy

National Research Council of Italy

Thanglong Instruments

Vietnam

Complementos y Suplementos Orgánicos del Perú

Peru

R‐Biopharm AG

Germany

Medical University in Lublin

Poland

Danone

France Canada

Maxxam Analytics 3M Food Safety

USA USA USA USA

FARRP, University of Nebraska

Abbott Nutrition Abbott Nutrition

NH Foods

Japan France

25. Popping, Bert

Merieux NutriSciences Mérieux NutriSciences

26. Szpylka, John (volunteered to chair the ERP, if needed)

USA

27. Yadlapalli, Sudhakar 28. Zweigenbaum, Jerry*

First Source Laboratory Solutions

India USA

Agilent Technologies

APPLICANTS WITHDRAWN FROM CONSIDERATION Kondratiev, Nikolay Federal State Budgetary Scientific Institution “all‐Russian Scientific Research Institute of Confectionery Industry”

Russia

Lowenthal, Mark Parker, Christine Rudenko, Oxana

National Institutes of Standards and Technology

USA USA

US Food and Drug Administration

Federal State Budgetary Scientific Institution “all‐Russian Scientific Research Institute of Confectionery Industry”

Russia

*Method author of methods submitted in response to issued Call for Methods

Applica

nts by R

egion

Burkina Fas Canada Cook Island Egypt Egypt France Germany India Indonesia

4% 4%

36%

4% 4%

Applica Per

A O nts by B spective

road s

cademia 9%

overnment 18%

Industry 71%

plicants

Co echnology 7% by Spe

cific Per

spective

nsulting 4%

CRO 21%

Researc 18%

F Manu 2

ood facturer 1%

Rapid echnology 11%

blic Health 18%

Qualification of Expert Reviewers: To qualify as an Expert Reviewer, the candidate must meet one of the following requirements:  Demonstrated knowledge in the appropriate scientific disciplines.  Demonstrated knowledge regarding data relevant to adequate method performance.  Demonstrated knowledge of practical application of analytical methods to bona fide diagnostic requirements. These qualifications must be clearly described in a CV submitted to the CSO and kept on file at AOAC headquarters.

CSO RECOMMENDED EXPERT REVIEW PANELISTS

Name

Affiliation

Country

1. 2. 3. 4. 5. 6. 7. 8. 9.

Almy, David

Neogen Corporation Mérieux NutriSciences

USA USA

Bhandari, Sneh

Boudichon, Francois

Danone

France Canada

Cho, France

Maxxam Analytics 3M Food Safety

Davenport, Ken Downs, Melanie Ehling, Stefan Farrow, Michael

USA USA USA USA USA Italy

FARRP, University of Nebraska

Abbott Nutrition Abbott Nutrition

Lawry, John

Covance

10. Monaci, Linda 11. Nguyen, Minh Hai 12. Nishiyama, Yasutaka 14. Siebeneicher, Susanne 15. Tuzimski, Tomasz 16. Yadlapalli, Sudhakar 17. Zweigenbaum, Jerry* 13. Popping, Bert

National Research Council of Italy

Thanglong Instruments

Vietnam

NH Foods

Japan France

Mérieux NutriSciences

R‐Biopharm AG

Germany

Medical University in Lublin First Source Laboratory Solutions

Poland

India USA

Agilent Technologies

18. Szpylka, John (Volunteered to chair ERP, if needed)

Mérieux NutriSciences

USA

*Method author of methods submitted in response to issued Call for Methods

Of the candidates that have served on ERPs before, Bhandari (2), Popping (13), and Szpylka (18) are members of at least one ERP. Recommendations for chair of this ERP are Bert Popping and John Szpylka, both of Merieux NutriSciences. Popping has been asked to consider being chair and we are awaiting his decision. If not, John Szpylka has volunteered to serve as chair on the panel, if needed. He made this offer to Shauna Roman during OMB core call on Monday, August 15, 2016. Currently, there are three candidates from Merieux NutriSciences, two candidates from Abbott Nutrition. OMB has approved ERPs from more than one location in the past.

Reco

Vietnam 6% mmende

Cana 5% d Candid

da France 5% ates by R

egion

France 11%

many 5%

Ger

USA 44%

Ind

Italy

6% an

Jap 6

Poland 6%

Reco

mmend P

Aca ed Candi erspecti

demia 9% NG 3% dates by ves

Broad

Governme 6%

Industry 82%

Cand

idates by

Specific

Perspect

ives

logy

Techno 12%

CRO 29%

Research 18%

R Tech 1

apid nology 8%

Food Manufacture 23%

AOAC SPSFAM Kombucha ERP: Statements of Expertise

CANDIDATE NAME

AFFILILATION

STATEMENT OF EXPERTISE

PDF PAGE NO.

CSO RECOMMENDATION

Neogen Corporation (USA)

I have worked for a food safety diagnostics manufacturer for over 9 years. Specifically, I have approximately five years of experience in development of food allergen diagnostic test kits. I am currently the group leader for development of food allergen diagnostic products. I am already involved in review panels of the allergens including gluten. We routinely analyze allergen here by various methods routinely. Food and nutritional analysis methodology, method validation, experimental design and data analysis, gas and liquid chromatography, spectrophotometry, ELISA, macro and micronutrient analysis, food additive analysis, allergen testing in food matrices and ingredients including spices I have a Ph.D. in Biochemistry, ran an immunology facility and designed commercial antibody programs and ELISA/Lateral Flow tests, and have been supporting rapid diagnostic test platforms for over 15 years. I have presented in allergen conferences and on allergen topics around the world and was Chair of the IAFP Food Chemical Hazard and Food Allergy PDG from 2012‐2013. I've participated in the AOAC and GMA allergen subcommittees and submitted/edited content for the Preventative Controls Alliance for the Allergen Training for PCA Qualified Individuals under FSMA. I am currently an Assistant Professor affiliated with the Food Allergy Research & Resource Program in the Department of Food Science and Technology at the University of Nebraska‐Lincoln. I have been working in the area of food allergens for more than eight years, over which time I have gained extensive experience with the development, evaluation, and use of various analytical strategies for food allergen detection. In addition, I have worked on other aspects of food allergy research, including the identification of novel food allergens, the evaluation of processing effects on food allergens and their subsequent detection, and purification and characterization of individual allergenic proteins. My current research focuses on the proteomics of allergenic foods, specifically the use of mass spectrometry for the identification,

Recommended

1. Almy, David

Mérieux NutriSciences (USA)

Recommended

2. Bhandari, Sneh

3. Boudichon, Francois

Danone (France) Maxxam Analytics (Canada)

Recommended Recommended

19 21

4. Cho, France

5. Davenport, Ken

3M Food Safety (USA)

Recommended

6. Downs, Melanie

FARRP, University of Nebraska

Recommended

characterization, and analytical detection and quantification of food allergens. I also have experience with the development and implementation of food allergen control programs in the food industry, including analytical validation of allergen preventive controls. Recommended by Jean Pan (co‐Chair of ERP on Gluten Assays). I have 5+ years of experience working for Abbott Nutrition as a senior scientist and subject matter expert on immunochemical‐ based assays. In support of a variety of hypoallergenic and gluten free products for the infant and adult consumer, experiences have included ELISA, LFA, Antisera generation and titer, method development, validation/verification procedures, and troubleshooting. I also have an extensive background using a variety of molecular biology techniques including real‐time PCR. I currently serve as the analytical subject matter expert for GMO detection testing. Efforts have included educating teams on ingredient and finished product testing capabilities as they pertain to international and domestic market requirements. I have twenty years experience in industrial biotechnology with functional expertise in molecular biology, protein biochemistry, protein mass spectrometry and function cross‐discipline integrations. Dr. Linda Monaci ‐ Lead researcher at the Institute of Sciences of Food Production (Bari) of the Italian National Research Council steering a group on the development of advanced and innovative methods for food allergen detection. After obtaining her PhD in 2002, she was post‐doctoral researcher in analytical chemistry at the University of Bari (Italy) undertaking the first investigations on allergenic proteins by MS based strategies. Then she was contracted for four years by Institute for Reference Materials and Measurements of the Joint Research Center – European Commission (IRMM, JRC) in Geel (Belgium), joining the Food Safety and Quality Unit and with her focus on the development of analytical methods for detection of food allergens. In 2009 was visiting scientist at Institute of Food Research (IFR) in Norwich (UK) to work jointly on a EU‐funded project basing her activity on the use

7. Ehling, Stefan 8. Farrow, Michael

Abbott Nutrition Abbott Nutrition

Recommended Recommended

32 34

9. Lawry, John

Covance

Recommended

10. Monaci, Linda

National Research Council of Italy

Recommended

of proteomic tools for the characterization of food allergens modifications. Her expertise and research activity span from the development of advanced MS methodologies tailored to the analysis and characterization of different chemical contaminants in foods to the development of innovative and fast methods for food allergen detection along the food chain. She contributed to several National and EU‐funded projects in the frame of food safety and quality and joint several working groups on food allergens. Invited speaker and chairman at several international conferences, she boasts an extensive scientific production on peer‐reviewed journals in the different fields of food contaminants analysis with a primary focus on MS‐based methodologies. Her major key‐results are in the field of food allergen research. I have been with NH Foods Ltd, which is manufacturing of food testing kits based on immunological methods. Our products include detection kit for food allergens, foodborne pathogens, and mycotoxins. I’m in charge of evaluating test kits. I led the project to obtain PTM certification of our test kit, NH Immunochromato O157 (certificate No. 091403). I have acquired basic knowledge and skill in instrumental analyses such as LC‐MS while I was working on plant metabolites. Although I’m not in charge of conducting such analyses these days, the knowledge enables me to evaluate the analytical methods. I have a lot of expertise on the topic of allergens and allergy. The ropic of my PhD thesis was the development of an immonotherapy for birch pollen allergy. At R‐Biopharm I was responsible for the Marketing of the products with participation in many international conferences with presentation of results of the company. Currently I am working in the research and development department for development of allergen ELISAs for food and feed. I am deeply involved in a project concerning detection of allergens by LCMS together with the university Fresenius in Idstein, they have a big expertise in using the LCMS for food proteins. Furthermore, I am connected to a lot of experts in the field of LCMS analysis in regards to food allergens. (says he is interested in serving on this ERP)

11. Nguyen, Minh Hai 12. Nishiyama, Yasutaka

Thanglong Instruments Thanks for your for support in the last.

Recommended Recommended

48 49

NH Foods

13. Popping, Bert

Mérieux NutriSciences

Recommended Recommended

55 62

14. Siebeneicher, Susanne

R‐Biopharm AG

15. Tuzimski, Tomasz

Medical University in Lublin

Recommended

1. Tuzimski's scientific interest include the theory and application of liquid chromatography, taking into considerations optimisation of chromatographic systems for separation and quantitative analysis of analytes in multicomponent mixtures. 2. Dr. Tuzimski is recipient of two grants from Polish Ministry of Science and Higher Education (2005‐2008 and 2009‐2011) for the study and procedure implementation of new methods of analysis of pesticides in original samples (e.g., water, medicinal herbs, wines, food, e.g, edible oils) with application of modern extraction (QuEChERS) and analytical methods combined with diode array scanning densitometry (and now also mass (MS) or tandem mass spectrometry (MS/MS)). 3. For CRC/Taylor & Francis Group, Dr. Tuzimski coauthored and coedited with Professor Joseph Sherma the book titled ‘High Performance Liquid Chromatography in Pesticide Residue Analysis’ (was published in 2015) and the book ‘Determination of Target Xenobiotics and Unknown Compounds Residue in Food, Environmental and Biological Samples’ (will be published 6/15/2018). Areas of expertise:  Laboratory management (Resource planning, Budgetary compliance, Forecasting and optimum utilization of Human Resource and Equipment to achieve Operational and Service Excellence).  Exposure to wide spectrum of analytical testing activities in the fields of Food and Agricultural ,Drugs and Pharmaceuticals ,Environmental, Minerals and Bio Analytical,  Sample preparatory techniques: Solid Phase Extraction, Solid phase micro extraction, Gel permeation Chromatography etc.  Hands on experience on Analytical Instrumentation :Mass Spectrometry various technologies like GCMSD, GCMS (Ion trap) ,GCMSMS, LCMSMS, GC TOF MS, LCMS Q‐TRAP, ICP MS, HRGC – HRMS (Auto Spec Waters).  Method development and validation as per standard methodologies specified by European Commission, USFDA, USEPA and other International guidelines. Collaborative studies as per national and international standards.  Participated in collaborative study toward method to detect agricultural residues at sub –parts–per‐billon levels in Soft drinks

16. Yadlapalli, Sudhakar

First Source Laboratory Solutions

Recommended

published as AOAC Official method 2007.08, First Action.  Participated in Multi lab study for Determination of metals in infant formula [AOAC 2011.19] (Approved for publications as AOAC official method)  Participated in Multi lab study for Estimation of vitamins in infant formula [AOAC 2011.11] Participated in Multi lab study for Estimation of iodine in infant formula [AOAC 2012.15] (Approved for publications as AOAC official method). I have 40 years experience in analytics. I have spent the last 25 years both at Eastman Kodak and Agilent Technologies specializing in LC/MS.

17. Zweigenbaum, Jerry*

Agilent Technologies

Recommended

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